Trials Sponsors Conditions Drugs Pricing

Conditions

Congenital Antithrombin Deficiency

Keywords

AntithrombinThrombosisPharmacokineticsHereditary Antithrombin DeficiencyCongenital Antithrombin Deficiency

Outcome Measures

Primary Outcomes (1)

To evaluate the pharmacokinetic profile of a single dose (50 IU/kg) of KW 3357 in subjects with congenital AT deficiency
July 2011

Secondary Outcomes (1)

To determine the safety and tolerability of a single dose (50 IU/kg) of KW-3357 in subjects with congenital AT deficiency
July 2011

Study Arms (1)

1

OTHER

Single group

Drug: KW-3357

Interventions

KW-3357Drug

50IU/mL, IV single dose

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female subjects at least 18 years of age with congenital Antithrombin deficiency (AT activity ≤60% of normal) in a stable condition without evidence of acute thromboembolic events
Signed IEC-approved Informed Consent Form

Sponsors & Collaborators

Kyowa Kirin Co., Ltd.
Industrylead
Kyowa Hakko Kirin UK, Ltd.
Industrycollaborator

Study Sites (8)

Department of Haemotogy, Haemastasy, Oncology and Stem Cell Transplantation, Hannover Medical School

Hanover, 30625, Germany

Center for Thrombosis and Haemostasis, Malmo University Hospital

Malmö, SE-205 02, Sweden

Dept Obst Gyn/Section for Women and Child Health/Clinical Trial Unit, Karolinska University Hospital

Stockholm, SE-171 76, Sweden

Treliske, Haematology Clinic, Royal Cornwall Hospital

Truro, Cornwall, TR1 3LJ, United Kingdom

Bristol Haemophia Care Centre, Bristol Haemotology and Oncology Centre

Bristol, BS2 8ED, United Kingdom

Department of Haemotology, Glasgow Royal Infirmary

Glasgow, G4 0SF, United Kingdom

MeSH Terms

Conditions

ThrombosisAntithrombin III Deficiency

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular DiseasesBlood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesBlood Protein DisordersThrombophiliaGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

Beverley Hunt, FRCP, FRCPath MD
St Thomas' Hospital, London, UK
PRINCIPAL INVESTIGATOR

Enrollment

16 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: OTHER
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 10, 2009

First Posted

July 13, 2009

Study Start

April 2009

Date type not reported

This date has not been verified as actual or estimated.

A Study of KW-3357 in Congenital Antithrombin Deficiency

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations